You have an idea for a new medical device – this is the starting point for all new product development projects. Where the project goes from there, however, the costs involved, and the timeline depends on a range of factors.
Examples include the complexity of the product, availability of funding, regulatory issues, medical trials, and more. Unfortunately, you have limited control over many of these factors.
That said, there is another factor that can have a substantial impact on the cost of product design as well as the time it takes to bring your new medical device to market. As an innovator, inventor, or entrepreneur with an idea for a new medical device, you do have significant influence over this factor.
Design Changes – a Necessary Part of New Medical Device Product Design
The factor we are talking about is design changes. This can be anything from superficial visual tweaks to major changes in how the product works or is used.
Making design changes is not only a part of the product design process – it is an essential part.
After all, an iterative design process is crucial to improving your product and ensuring it performs according to its intended use.
In other words, design changes to improve your product are important to making the product a success.
Crucially, however, the impact of design changes on development costs and timescales differs substantially depending on when those design changes take place.
The Earlier the Better
There is a well-known cost of design changes graph in the product design industry. It shows the potential cost difference of making design changes at various stages of a product’s lifecycle. Here is a representation of the image:
In summary, the later you make a change in the design of your product, the greater the cost.
We’re not talking small increases in cost here, either, as changes after the design is frozen and production tooling has been created can be thousands of times more expensive than making a change in the concept stage of the product’s development.
Impact on Time to Market of Late-Stage Design Changes
In addition to the cost implications, the later a design change occurs, the more work has to be redone. The change request could impact other aspects of the medical device too, meaning those aspects will also have to be reworked.
For example, a component might have to be redesigned to facilitate the design change but redesigning this component might also necessitate the redesigning of other components. This adds time to the development process.
In addition, design changes often mean new 3D models or CAD drawings have to be created. New prototypes of the product will have to be produced too if the design change request comes in after the prototyping stage.
It’s also likely the product will need to go through the verification process again and may even need re-validated. This causes further delays.
It’s easy in these situations for a product development timescale to drift by weeks or even months.
The Solution – and the Influence You Have
The straightforward solution to preventing these problems from occurring is to make decisions as early in the design process as possible.
At Arrotek, we have a six-step product design process to facilitate this decision-making. The aim is to establish an iterative design process, provide you with expertise from our design engineers, and encourage your feedback.
The process also involves getting sign-off at each step before moving forward to the next one, eliminating the unnecessary reworking of elements and the time delays that result.
Our experienced product design project managers lead the six-step process as we turn your idea into a working product. You play a critical role, however, particularly in relation to ensuring decisions are made early and are then adhered to.
By following this approach, you will keep a cap on design and development costs, and you will keep to your schedule for bringing the product to market.
